Medical valve and method of use

ABSTRACT

A closed system, needleless valve device includes a generally tubular body defining an internal cavity. On the proximal end of the body there is an opening which is preferably sufficiently large to receive an ANSI standard tip of a medical implement. The distal end of the body has a generally tubular skirt. The valve also includes a hollow spike having a closed tip. The spike includes at least one longitudinal 18-gauge hole located distal the tip, and is seated inside the cavity such that the tip is below the proximal end of the body. An annular support cuff is connected to the spike which seals off a portion of the cavity of the body such that an upper cavity containing the tip is defined. The valve also includes a plastic, resilient silicone seal which fills the upper cavity and opening and covers the tip of the spike so as to present a flush surface. An adaptor enables the valve to be attached to a resealable container.

This application is a continuation of U.S. application Ser. No.10/630,131, filed Jul. 30, 2003, pending, which is a continuation ofU.S. application Ser. No. 10/163,403, filed Jun. 5, 2002, now U.S. Pat.No. 6,669,673 which was a continuation of U.S. application Ser. No.09/569,712, filed May 9, 2000, now U.S. Pat. No. 6,572,592, which was acontinuation of U.S. application Ser. No. 08/905,370, filed Aug. 4,1997, now abandoned, which was a continuation of U.S. application Ser.No. 08/334,846, filed Nov. 4, 1994, now U.S. Pat. No. 5,685,866, whichwas a continuation of U.S. application Ser. No. 08/096,659, filed Jul.23, 1993, now U.S. Pat. No. 5,695,466, which was a continuation-in-partof PCT Application No. PCT/US92/10367, filed Dec. 1, 1992, nowabandoned, which was continuation-in-part of U.S. application Ser. No.07/813,073, filed Dec. 18, 1991, now abandoned. This applicationincorporates by reference the above identified applications in theirentireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a closed, patient access system whichautomatically reseals after administering medication using a standardmedical implement that directly connects with the system without theneed of any intermediary needles, caps or adaptors. A two-way valveeliminating dead space is used which includes a seal which, upon beingcompressed by the medical implement, is pierced to open the valve andreseals upon being decompressed, maintaining a fluid tight seal even athigh pressures and after repeated uses.

2. Description of the Related Art

The manipulation of fluids for parenteral administration in hospital andmedical settings routinely involves the use of connectors and adaptorsfor facilitating the movement of fluids between two points. Most fluidconnectors and adaptors employ needles to pierce a septum coveringtubing or to pierce the septum of a medicament container of fluid. Fluidthen passes from the container or fluid filled tubing into a syringe orsecond set of tubing. These connectors and adaptors often havemechanical or moving parts. Since the ready passage of fluids throughthe connectors and adaptors is often critical to patient survival, it isimperative that the connectors and adaptors function reliably andrepeatedly. Adaptors and connectors that malfunction during use may belife-threatening. The more mechanical or moving parts such as springsand diaphragms, the more likely that they will function improperly.Improper functioning can result in the introduction of air embolismsinto a patient. Thus, the fewer the mechanical parts, the more theseconnectors can be relied on and the better they will be accepted by themedical community.

Many connectors or valves, especially those employing several mechanicalcomponents, have a relatively high volume of fluid space within them.This “dead space” within the device prevents accurate introduction ofprecise fluid volumes and provides an opportunity for contamination upondisconnection of the device. Connectors and adaptors often includevalves that permit or interrupt the flow of fluid along the course offluid travel. Several of those commonly in use employ metal needles topuncture sterile seals. Such connectors are generally designed toaccommodate fluid flow in one direction. This means that the fluid linemust have connectors and tube aligned in complementary directions. Theseconnectors often require further manipulation if, for example, the valveis inadvertently assembled in a direction that will not facilitate fluidflow. These manipulations increase handling, thereby increasing both therisk of contamination and the amount of time required to establish thefluid connection.

Metal needles employed as part of connector devices increase the risk ofpuncture wounds to the user. The needles used in these devices oftenhave through-holes placed at the tip of the needle. Connection of thevalve with a flow line involves piercing the needle through a sealedseptum. Through-holes placed at the needle tip can core the septum andrelease free particulates into the flow line. Such an event can provefatal to a patient. Such through-holes may also become clogged easilywith material from the septum.

Reusable connectors and adaptors are preferred for medical applicationssince components must often be added or removed from a fluid lineconnected to a patient. Reusable connectors, however, are difficult tokeep sterile. Sometimes caps are employed to cover the connector to keepit sterile. Frequently, these caps are lost, or simply not used becausethey are not readily available when needed.

A closed, patient access system that is easy to use and employs only avalve device in communication with the patient that need not be cappedor interconnected with the medical implement through a needle oradaptor, is swabbable, is sufficiently durable to maintain its functionafter several manipulations, and maintains a fluid-tight seal at highpressures, would be of great benefit to the medical community.

SUMMARY OF THE INVENTION

The valve of this invention has several features, no single one of whichis solely responsible for its desirable attributed. Without limiting thescope of this invention as expressed by the claims which follow, itsmore prominent features will now be discussed briefly. After consideringthis discussion, and particularly after reading the section entitled,“DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS,” one will understandhow the features of this invention provide its advantages, which includesafety, reliable and repeatable performance, elimination of dead space,simplicity of manufacture and use, and employment of a valve that isswabbable after use to provide sterility and has a fluid-tight seal athigh pressure.

This invention is a closed, patient access system which automaticallyreseals after administering medication using a medical implement thatdirectly connects with the system without the need of any intermediateneedles, caps or adaptors. A two-way valve is employed utilizing areusable seal that may be repeatedly pierced by an enclosed, protected,non-metallic spike rather than an exposed metal needle. The valvefacilitates fluid, particularly liquid, transfer while maintainingsterility. The valve is easy to use and is capable of locking in place.After use, the valve is swabbed in the conventional manner with asuitable substance to maintain sterility. The design of the valve avoidsaccidental needle sticks. As will be discussed in detail below, thevalve is useful as a medical connector or adaptor to enable liquid flowfrom a sealed container.

The first feature of this invention in that the valve has a bodyincluding wall structure defining an internal cavity having a proximalend and a distal end. The cavity has an open space into which the sealis pushed, and preferably has a plurality of radial indentations in thewall structure that are adjacent the seal to accommodate the expansionof the seal upon compression. The proximal end has an openingsufficiently large to receive a delivery end of a medical implementwhich transfers fluid through the delivery end. In most applications,the delivery end of the implement is tapered, and the wall structureadjacent the opening is tapered inward so that the wall structure andthe tapered delivery end fit snug against each other upon insertion ofthe delivery end into the opening. The proximal end of the cavitypreferably is adapted to fit snug with an ANSI (American NationalStandards Institute, Washington, D.C.) standard end of the medicalimplement. Typically, the implement is a syringe, a connector orinlet/outlet of an IV set, or any one of a wide variety of conduits usedin medical applications.

The second feature is that the spike has a tip with at least one holelocated at or near the tip, and a passageway in communication with thehole that allows fluid to flow through this hole. The spike is seatedinside the cavity such that the tip is inward of the proximal end and isenclosed within the cavity. Preferably, the hole is in a side of thespike adjacent the tip and is elongated, having a size of 18 gauge orgreater. The tip may be sharp or slightly rounded. More than one hole isdesirable for many applications, and three, symmetrically located holesinward of the proximal end are preferred. The spike may include at leastone rib which allows air to enter a space between the seal and thespike, thereby facilitating the sealing of the opening when theimplement is removed. The spike may have a substantially conical shape,and the seal has a complementarily, substantially conical shaped cavitywithin it conforming to the shape of the spike. The spike is disposedwithin this conical cavity and the seal covers the tip. The tip may beimbedded in the proximal end of the seal or withdrawn into the conicalcavity. Preferably, the tip of the spike has a plurality of facets whichmeet within a recess. The preferred spike should be able to penetratethe seal repeatedly without tearing the seal. Rough edges at the tip maypresent a tear problem. During injection molding of the preferredplastic spike, facets of the tip will abut along a “parting line,” andcould form a rough edge which may tear the seal. This problem is avoidedwhere the parting line is buried in a recess. Any rough edge at thisparting line is disposed within a recess, so the seal material movesover the recess and does not contact the rough edge.

The third feature is that the resilient seal is adapted to be moved intoa compressed state upon insertion of the tip of the medial implementinto the opening and returns to a decompressed state upon removal of thetip. The seal in the decompressed state has a section which fillsessentially completely a portion of the cavity adjacent the opening. Theseal section bears against the wall structure near the opening to sealthe opening. In the compressed state, the seal section is pushed by thedelivery end of the medical implement away from the opening and into thecavity. A fluid tight seal is maintained between the seal section andthe wall structure as the seal is moved into the compressed state. Theseal section bears against the wall structure as the seal is movedinward into the cavity by the tip of the medical implement. And mostimportantly, the delivery end and the seal are adapted to engage so thatwhen the tip of the spike pierces the seal there is essentially no deadspace between said delivery end and the seal. Consequently, apredetermined dosage amount of medication is transferred in its entiretyto the patient using this invention, with none to the prescribed amountbeing collected in dead space in the valve. The delivery of an exactamount of medication may be critical in some situations whenchemotherapeutic agents are being administered or small children arebeing treated.

A fluid tight seal is maintained over repeated opening and closing ofthe valve, and the seal has on its external surface a recess whichprovides an air pocket to facilitate the movement of the seal.Preferably, the seal presents an essentially flush surface with theproximal end of the cavity. In one embodiment, the proximal end of theseal is substantially flat, the seal is made of a material having ahardness of from 30 to 70 Shore units such as, for example, a siliconepolymer. The seal may include a cup-like flange adapted to engage thebody near the proximal end of the cavity. A preferred embodiment of theseal comprises of a series of O-ring elements stacked together andconnected to form a unitary structure. The O-ring elements haveincreasing diameters, with the smallest diameter element begin adjacentthe proximal end of the cavity. The proximal end of the seal may beprecut to form a tiny orifice therein that allows the tip of the spiketo pass therethrough easily upon compression of the seal. Preferably,the proximal end of the seal has a truncated conical shaped segmentdisposed within the cavity. The seal may also have a centrally located,anti-vacuum, saucer like depression therein, which does not interferewith the ability of the exposed, proximal end of the seal being swabbedwhen desired.

The fourth feature is that the body and spike are two separatecomponents of the valve that are securely attached to each other byassembly of, and interlocking, of the body and spike. The body has afirst locking element near the distal end of the cavity, and the spikehas a second locking element adapted to interlock with said firstlocking element upon assembly. The seal has a lip extending beyond thedistal end and positioned between the first and second locking elementsso that, upon assembly, the lip is compressed between the lockingelements to provide an essentially fluid tight seal upon interlocking.

The fifth feature is that the medical valve includes a support memberconnected to the spike which seals off the distal end of the cavity. Thesupport member may have a Luer-Lock type connector element that enablesthe valve to be removably attached to, for example, a fluid lineconnected to a patient. The support member may also be in the form of anadaptor that enables the valve to be removably attached to a fluiddispenser or container. When used to dispense fluids from a container,the spike has a pair of opposed tips, respectively at the distal andproximal ends of the spike. The tip at the distal end of the spikepierces a cover member which seals the container. A radial slit on theadaptor enables it to deform reversibly sufficiently to fit snugly ontosaid container.

The sixth feature is that the seal has a proximal end including apressure responsive element disposed on an inner surface of the sealadjacent the opening. The pressure responsive element in thedecompressed state closes any orifice in the seal at the proximal end ofthe seal to provide an essentially fluid-tight seal while in thedecompressed state. The pressure responsive element enables the valve tomaintain a fluid-tight seal even at very high pressures sometimesexperienced in medical applications, particularly when the valve isconnected to a patient's artery. The valve of this invention will remainclosed even when the pressure inside the valve is above 6 pounds persquare inch (psi), and it can withstand pressures above 30 psi.Typically, the pressure responsive element is a section of the sealhaving an entryway into a precut orifice. This section has asubstantially cylindrical configuration and is surrounded by an annularspace which is filled with pressurized fluid. The center of the memberand the annular space are coaxial with the entryway to the orifice. Thepressurized fluid fills the annular space to apply pressure thatcompresses the cylindrical section to tightly close the entryway to theorifice. Preferably, the pressure responsive element has an anti-tearelement.

In accordance with this invention, a known, prescribed, predeterminedamount or dosage of medication may be transferred from the remote sourceto the patient directly, so that essentially none of said predeterminedamount is collected in dead space in the valve. In other wordsessentially all the prescribed dosage is received by the patient and notlost in the valve. Thus, this invention also includes a method oftransferring fluid from a remote source to a patient. This inventionalso includes transfer of fluid from the patient to a remote source.This is possible because the valve of this invention provides two-waycommunication. The fluid is transferred to the patient by applyingpressure the fluid as it passes through the implement so that thepressure applied to the fluid is greater than the pressure of fluid inthe patient, enabling transfer from the remote source to the patient. Toachieve transfer of fluid from the patient to the remote source, thepressure of fluid in the patient is greater than the pressure at theremote source, causing fluid to flow from the patient to the remotesource. This invention also includes a method of transferring fluid in acontainer having an open mouth covered by a cover member which seals theopen mouth. The fluid is caused to flow from the container through thepassageway by creating a differential in pressure. Preferably, the valvehas an adaptor having a radial slit for allowing the adaptor to deformreversibly sufficiently to fit snugly onto said container.

BRIEF DESCRIPTION OF THE DRAWINGS

The preferred embodiments of this invention, illustrating all itsfeatures, will now be discussed in detail. These embodiments depict thenovel and non-obvious method and valve of this invention shown in theaccompanying drawing, which is for illustrative purposes only. Thisdrawing includes the following Figures, with like numerals indicatinglike parts:

FIG. 1 is a perspective view of the first embodiment of the valve ofthis invention.

FIG. 2 is an exploded perspective view of the valve shown in FIG. 1illustrating the spike, seal, and the body or housing components of theinvention.

FIG. 3 is a longitudinal cross-sectional view of the assembled valve ofFIG. 1.

FIG. 4 is a schematic, longitudinal, cross-sectional view of theassembled valve of FIG. 1 before compressing that seal.

FIG. 5 is a schematic, longitudinal, cross-sectional view similar toFIG. 4 showing the valve during compression of the seal.

FIG. 6 is a perspective view of a second embodiment of the invention.

FIG. 7 is a longitudinal cross-sectional view of the valve of FIG. 6.

FIG. 8 is a schematic illustration of an ANSI delivery end of a medicalimplement compressing the seal of the valve of this invention.

FIG. 9 is a side elevation view, partially in cross-section, of a thirdembodiment of the seal.

FIG. 10 is a longitudinal cross-sectional view of the assembled valve ofFIG. 1 using the seal of FIG. 9.

FIG. 11 is a longitudinal cross-sectional view of the assembled valve ofFIG. 1 using a fourth embodiment of the seal.

FIG. 12 is a longitudinal cross-sectional view of the assembled valve ofFIG. 1 using a fifth embodiment of the seal.

FIG. 13 is a longitudinal cross-sectional view of the sixth embodimentof the seal.

FIG. 14 is a longitudinal section of the seal shown in FIG. 13 used inconnection with the spike device shown in FIG. 2.

FIG. 15 is a longitudinal partial cross-sectional view of a seventhembodiment of the seal of this invention.

FIG. 16 is a longitudinal cross-sectional view, after assembly, of theembodiment of the valve shown utilizing the seal of FIG. 15.

FIG. 17 is a longitudinal cross-sectional view, after assembly, of theeight embodiment of the valve of this invention.

FIG. 18 is a longitudinal cross-sectional view, after assembly, of theninth embodiment of the valve of this invention.

FIG. 19 is a side elevation view, after assembly, of the seal and spikeshown in FIG. 14 connected to the body or housing shown in FIGS. 20 and21.

FIG. 20 is a cross-sectional view taken along line 20-20 of FIG. 19.

FIG. 21 is a perspective view, with sections broken away to show thewall structure of the cavity containing the seal shown in FIGS. 13 and14.

FIG. 22 is a greatly enlarged, cross-sectional view taken along line22-22 of FIG. 14.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The term “proximal” is used to denote the end of the valve and othercomponents at or near the spike tip 32 in FIGS. 2 through 5, 10 through12, 14 and 16, and at or near the spike tip 60 in FIG. 6, and at or nearthe seal cap 92 in FIGS. 8, 9, 13 through 19. The term “distal” is usedto denote the opposite end of the valve, or spike tip, or seal. The term“medical implement” is used to denote any medical tool known to those ofskill in the art that can connect to the present invention andfacilitate the passage of fluids, particularly liquids, through theinstant invention. Examples of medical implements that are contemplatedinclude, but are not limited to, tubing, conduit, syringes, IV sets(both peripheral and central lines), piggyback lines, and othercomponents which can be used in connection with medical valve. Medicalimplements are commercially available in standard sized. Thus, either orboth ends of the valve of this invention can be provided with fittingsto accommodate such standard size medical implements.

As best shown in FIGS. 1 and 2, the first embodiment of the invention,valve 10, includes a valve body or housing 12, a spike element 24, and aseal 36. The seal 36 is prepared from a resilient material that isflexible, inert, impermeable to fluid, and readily pierceable by thespike 26. In the embodiment shown in FIG. 13 depicting an alternateshaped seal 36 d, this seal 36 d has a precut slit 11 in its proximalend. This provides a tiny orifice through which the tip 32 of the spikeelement 24 may easily pass, yet still provides a fluid tight seal uponwithdrawal of the spike element. These three components are assembled,as depicted in FIG. 3, with the spike element 24 enclosed to preventaccidental sticks. FIG. 2 illustrates how the housing 12, seal 36, andspike element 24 are attached without the need to use any adhesive orother bonding agent or process. Mechanical connection which provides afluid tight closure is attained as is discussed subsequently. As shownin FIGS. 4 and 5, the seal 36 moves within the housing 12, being piercedby the spike element 24 to expose the tip 32 of the spike element 24 toallow fluid to flow through the valve 10.

Referring to FIG. 1, one preferred embodiment of housing 12 has abell-shaped skirt 16 and an upper, preferably cylindrical, conduit 20.The skirt 16 is integral with, and connected by an annular ring 14, tothe upper conduit 20. The skirt 16 creates a shield for an inner conduit18 of the spike element 24. This inner conduit 18 is preferablycylindrical in shape, and slightly tapered. Inner conduit 18 and upperconduit 20 comprise aligned hollow tubes so that inner conduit 18 andupper conduit 20 are in fluid communication with one another when thespike element 24 pierces the seal 36. there is an annual lip 25surrounding a circular opening 25 a in the top of the conduit 20 (seeFIG. 2).

In the first embodiment, the upper conduit 20 is adapted to receive thetip or nose 48 of an ANSI standard syringe 46 (see FIGS. 4 and 5). Itis, however, contemplated that the outer diameter of the upper conduit20 can be of any size to accommodate the attachment of other connectordevices thereto. Advantageously, the proximal end of the upper conduit20 can be equipped with a locking mechanism to facilitate locking of thevalve 10 to a variety of connector devices. For example, referring toFIG. 1, locking ears 22 near the proximal lip 25 of housing 12 arepreferably provided such that the housing 12 can be locked into anycompatible Luer-Lock device known to those with skill in the art. Forexample, referring the FIG. 19, conventional Luer-Lock threads 180 canbe provided on the outer diameter of upper conduit 20.

Referring to FIG. 2, the spike element 24 has at its distal end theinner conduit 18 and its proximal end a hollow spike 26 which isintegral with the inner conduit. The inner conduit 18 and spike 26present a continuous passageway for fluid during use. An annular cuff 28on an intermediate portion of the spike element 24 is integral with, andinterconnects, the inner conduit 18 and the spike 26. As illustrated inFIG. 3, the rim 28 a of the cuff 28 abuts the underside of the innerring 14, and has an annular detent 28 b that snaps into an annulargroove 14 b in the underside of the ring. The cuff 28 services twofunctions. First, it serves as an attachment device to the underside ofthe annular ring 14. Second, it serves as a support and attachmentdevice for the seal 36.

The hollow spike 26 has a tapered conical shape, ending in a sharp,pointed tip 32. Preferably, along the length of the spike are raised,protruding ridges 30. These raised ridges 30 extend from the surface ofthe spike preferably between 0.2-2.0 mm. The ridges 30 are preferablyaligned along the length of the spike as illustrated in FIG. 2. Theseridges 30 serve to break any vacuum created when the spike 26 is sealedas described hereinbelow. Modifications to the alignment and orientationof the ridges are discussed hereinbelow in association with theirfunction. Just distal the spike tip 32, there is situated at least onelongitudinal through-hole 34 to permit fluid communication between theinner conduit 18 and the upper conduit 20. Preferably, there are threethrough-holes 34 within about 0.200 inch from the spike tip 32. Thesethrough-holes 34 may be of any size, however, the larger the size of thethrough-holes the greater the fluid flow rate through the valve 10. In apreferred embodiment, the size of the through-holes 34 are 18-gauge toprovide a flow rate three times that of a standard 18 gauge needle.

The seal 36 has a seal cap 40 with a generally flat top surface 40 b, anoutwardly tapered sidewall 38, and a lower lip 42. Its interior ishollow to provide the conically shaped cavity 37 (FIG. 3). Thus, theseal 36 slips easily over the spike element 24 to fit snugly within thecavity 37. The seal lip 42 is seated within the annular cuff 28 andwedged between the cuff and the underside of the ring 14. There arelongitudinal grooves 43 (FIG. 2) along the length of the seal 36 whichprovide air pockets that facilitate compression of the seal 36 duringuse. The grooves 43 may be of variable shape or size to facilitate sealcompression. In the first embodiment, there is a single groove 43 whichcompletely surrounds the seal 36 between the seal cap 40 and the lip 42.

The base of the seal 36 has a width such that the seal lip 42 fitssnugly into the annular cuff 28. The hollow interior or cavity 37 (FIG.3) of the seal 36 is preferably tapered to conform internally to theshape of the spike 24, having a wall portion 44 which contacts the spike24 distal seal cap 40. The exterior of the seal 36 is sized and shapedto fit inside the upper conduit 20 of the housing 12. The cap 40 resealsthe valve 10 when the top surface 40 b is above the through-holes 34.Preferably, the cap 40 substantially fills the opening 25 a in the topof the conduit 20. Thus, after assembly, the top surface 40 b of theseal cap 40 is essentially flush with the lip 25, so that the lip 25 andseal cap 40 can be swabbed with alcohol or other disinfectant withoutleakage of disinfectant into the valve 10. It is important that thesurface 40 b be exposed so that it may be swabbed with a disinfectant.

As best shown in FIG. 3, the spike 24, with contiguous inner conduit 18,is affixed to the housing 12 through the association of the externalportion of annular cuff 28 and the internal portion of annular ring 14.Although not necessarily required, these two pieces may be affixed byany one of a variety of methods known to those of skill in the artincluding, but not limited to, heat sealing, glue, pressure lock,bonding or the like. The seal 36 fits into the annular cuff 28 and isheld in place by an internal lip 27 along the internal portion of theannular ring 14 of the housing 12. The length of the spike 24 is suchthat, after assembly, the tip of the spike rests below the plane definedby the lip 25 of the housing 12. Preferably, the spike tip 32 isapproximately from 0.525″ to 0.1″ below the lip 25 of the housing 12.The seal 36 fits snugly against the spike 24 and is essentially flushwith the lip 25 of the housing 12. The spike tip 32 is thus embeddedwithin the seal cap 40 prior to use or may be approximately 0.025″distal the seal cap 40 when the valve 10 is in the closed position. Theinner conduit 18 is partially shielded by the bell shaped skirt 16 ofthe housing 12 (see FIGS. 1-3). The inner surface of the bell shapedskirt 16 preferably has protruding threads 44 as an optional lockingmechanism for attaching a medical implement thereto. Further, othermedical devices can be pressure fit over the outer portion of innerconduit 18 without direct association with the protruding threads 44.

During use, the invention is designed to adapted as a two-way valve. Theorientation of the valve is independent to fluid flow and dependent onthe preferred orientation of the preexisting connections. Thus, theinvention can be used as a valve connector for an intravenous central orperipheral piggyback connector in either orientation. Parenteral fluidis delivered to patients through tubing such that the liquid flows froma container through a needle into the patient. The containers arefrequently changed or additional fluid bottles are added. The inventiondisclosed herein is designed to interconnect medical implements alongthe route of fluid delivery to the patient. However, the invention isalso useful in any environment in which a resealable fluid valve isdesired. During use, a connector of the appropriate size is fitted overthe inner conduit 18. Locking can be achieved by a Luer-Lock mechanism,a pressure fit or any other locking mechanisms know to those with skillin the art, as described above. Thus, in one example, fluid passes fromthe inner conduit 18 into the spike 26. However, fluid flow is locked inplace by the seal 36.

FIGS. 4 and 5 illustrate valve activation. In FIG. 4, the medicalimplement connecting to the proximal end of the valve 10 is a syringe46. However, this connecting implement could be any number of medialimplements known to those of skill in the art. The nose 48 of thesyringe 46 is placed on the seal cap 40 inside the lip 25 of the housing12. The application of pressure on the syringe 46 in the direction ofthe arrows, as illustrated in FIG. 4 creates pressure on seal cap 40.The resulting downward pressure compresses the seal 36. This pushes thetip 32 of the spike 26 through the seal cap 40 to expose thethrough-holes 34. Compression is facilitated by the grooves 38. Fluid isnow able to flow into the syringe 46, or vice versa, depending onwhether fluid is to be withdrawn from the patient or medication injectedinto the patient. FIG. 5 shows valve 10 opened by insertion of the nose48 of the syringe 46 into the opening 25 a. a syringe plunger 49 in thesyringe 46 is retracted thereby creating a vacuum to draw fluid throughthe valve 10 into the syringe. For intravenous applications, the valve10 can be orientated in the position diagramed in FIGS. 4 and 5, or itcan be rotated 180° such that fluid flows in the opposite direction.

Upon removal of the syringe from spike 26, as shown in FIG. 4, the seal36 is free to return to its original shape and over through-holes 34.The ability of the seal 36 to return to its original shape is determinedby the resiliency of the material used to prepare the seal 36. Inaddition, the ability of the seal 36 to return to its original shape isfacilitated by the protruding ridges 30 formed on the external surfaceof the spike. During compression, a vacuum may form in the area betweenthe spike 26 and the seal 36, thereby preventing the seal 36 fromreturning to its original position. The protruding ridges permit air topass along the spike/seal interface to prevent vacuum formation andallow free return of the seal. The ability of the seal 36 to deformreversibly and return to its original position is particularly usefulbecause (1) it immediately stops fluid flow through the valve 10, (2) itcovers the recessed spike 26 to maintain its sterility, and (3) itreduces the risk that the spike could inadvertently pierce anotherobject or person. In addition, since the valve 10 lacks movable parts,except for the seal, it is unlikely that when the seal 36 is pusheddown, the valve 10 would fail to function.

Advantageously, the through-holes 34 are located relatively low on thespike 26. Thus, the through-holes 34 are seated relatively early in theprocess as the seal 36 returns to its original configuration with thevalve 10 is closed. In one preferred embodiment the through-holes 34 arelocated 0.075″ below the spike tip 32 (see FIG. 2). Additionally, thethrough-holes 34 are sealed if the seal 36 does not fully return to itsoriginal configuration depicted in FIG. 4. Further, the ability of theseal 36 to return reversibly to its original position permits the reuseof the connector valve 10. Following disconnection, and before reuse,the surface of pierced seal cap 40 is essentially flush with the housing12. Thus, this flush surface can, advantageously, be sterilized withalcohol or other surface decontaminating substances. The skirt 16 andupper conduit 20 advantageously shield both connections from thesurrounding environment to protect the sterility of the connection.Further, both the skirt 16 and upper conduit 20 function as collectionreservoirs to prevent fluid from dripping from the valve 10 duringmanipulation.

A cover cap (not shown) can be supplied to fit over the upper conduit 20as further protection for the seal surface between use. Such a covercap, however, is not needed to maintain sterility since the seal 36 maybe swabbed with a disinfectant after each use. The reversibility of theseal 36 makes the valve 10 particularly attractive as a connector valveto provide fluid communication between two fluid lines. Therefore, thepresent invention provides for placing a first fluid line incommunication with a second fluid line using the valve disclosed herein.The reversibility of the valve 10 permits multiple fluid lines to besuccessively added, for example, to a fluid line in direct communicationwith a patient's vein. Since the valve is easily sterilizable andsealable, fluid lines can be added and removed without disconnectingvenous contact.

The valve 10 is preferably prepared from a hard plastic, but it isadditionally contemplated that the valve could be prepared from othermedically inert materials known to those in the art. the spike element24 is preferably prepared from the same material as the housing 12. Oneparticular advantage of this invention is that it does not rely on theuse of metal needles. This dramatically reduces the risk of skinpuncture during use and manufacture. Further, the upper conduit 20serves as a shield to the spike 26 such that skin puncture is furtherreduced. The spike 26 need only be strong enough to penetrate the sealcap 40, or if necessary, to pierce a connecting septum.

In the embodiment of the invention illustrated in FIGS. 2-4, thethrough-holes 34 are placed distal spike tip 32. This placement providestwo important advantages. First, the placement of the through-holes 34facilitates resealing of the valve 10 after use. Second, if thethrough-holes were placed at the spike tip 32, the holes 34 may core theseal cap 40 thereby introducing seal particulate into the fluid flow andpossibly plugging the holes 34. Thus, the longitudinal placement of thethrough-holes distal spike tip 32 prevents the introduction ofparticulates into the fluid path and/or plugging of the through-holes34. It is additionally contemplated that the number and diameter of thethrough-holes 34 can be adjusted to accommodate different fluidvelocities. In a preferred embodiment, the preferred velocity of fluidpassing through the through-holes 34 is equal to or greater than theflow rate through an 18 gauge needle. Through-holes larger than 18 gaugewill, of course, facilitate greater fluid velocities.

An important advantage of the invention is that the valve 10 has verylittle dead space, thus the volume of liquid entering into the valve issubstantially equivalent to the volume of fluid leaving the valve.Further, the total equivalent fluid volume of the valve is very smallsuch that the volume of fluid flowing through the system in order toplace the valve in fluid communication with a medical implement such asa syringe 46 is substantially zero.

Alternate Embodiments

In another preferred embodiment of the invention, illustrated by FIGS. 6and 7, a disposable sterile adaptor valve 50 is provided to function asa resealable lid for a container (not shown) of fluid. The fluid canthus be removed from the fluid container or permitted to flow from thecontainer into a medical implement adapted to house fluid in a sterilemanner. As is the conventional practice, an open mouth of the containerwill ordinarily be sealed with a cover member (not shown).

FIG. 6 shows an adaptor valve 50 having a body including an adaptorskirt 52. The adaptor skirt 52 will preferably fit snugly over the openmouth of the container. The skirt 52 may be of any size to accommodate arange of container sizes. A lengthwise slit 54 is preferably provided inat least one location along the length of the skirt to ensure a snug fitbetween the skirt 52 and the container. A chamber 56, preferably tubularin configuration, extends upward from the skirt 52 and is similar inconstruction and design to the upper chamber 20 of the first preferredembodiment. Similar to the first embodiment, the proximal portion of thevalve contains a locking mechanism 59 that preferably comprises aLuer-Lock device or other locking device known to those of skill in theart.

As depicted in FIG. 7 a spike 58 extends upward through a tubularchamber 56. A spike tip 60 is preferably recessed from a proximal lip 62of the tubular chamber 56. In a closed position, this tip 60 is coveredby a seal 64, which is essentially the same as seal 36. Protrudingridges 66 and seal grooves 68 facilitate seal compression in the openposition and promote closure following use. Thus, in the closed positionas illustrated in FIG. 7, the seal 64 covers the through-holes 70 toprevent fluid out-flow from the container. The adaptor valve 50 containsa second spike 72 which points in the opposite direction as spike 58.These spikes 52 and 72 are in fluid communication with each other. Thespike 72 extends downward inside the adaptor skirt 52. The two spikespreferably form one component of the valve 50 while the skirt 52 andupper chamber form a second component. These two components can beassembled in a manner like that of the valve 10. The spike 72, like thespike 58, has longitudinal through-holes 74 and a tip 76. Thethrough-holes 74 are located inward of the tip 76. The adaptor valve 50is thus useable with containers holding sterile medicament having acover or septum seal at the open mouth of the container. Examples ofcontainers with such seals contemplated for use with this inventioninclude dosage bottles for intramuscular injector antibiotic containersor the like. However, it is also contemplated that the valve 50 can beadapted with its own seal and locking mechanism to permit the valve tobe employed on a variety of containers for medicaments or other fluids.Medicaments in these types of containers are preferably maintained understerile conditions and the volume and nature of the medicament is suchthat multiple aliquots are intermittently removed over time. If themedicament is reconstituted, then, during use, any covering over theopening on the container is removed to reveal the rubber septum. Theadaptor valve 50 is placed over the septum and direct pressure isapplied to pierce distal spike 72 through the septum and into thecontainer. A syringe or the like can then be applied, as depicted inFIG. 4, in association with the first preferred embodiment, to withdrawfluid from the container. The pressure of the nose 48 over the spike 58pushes spike tip 60 through seal 64. At the same time, seal 64 is pushedback and compresses. Compression is accommodated by seal grooves 68.Fluid is withdrawn from the container and the syringe is removed fromthe spike 58. Release of the pressure applied to seal 64 permits theseal to return to its original configuration. The spike ridges 66facilitate seal reversibility.

Often the ingredients housed in containers are those that ca belyophilized at purchase. Lyophilized ingredients require reconstitutionbefore use. If the medicament requires reconstitution before use, thensterile water, saline, or other fluid can be introduced into thecontainer before fluid is extracted. The two-way nature of the valvepermits this without any special adaptation. After the syringe isremoved, the adaptor valve 50 automatically seals. Subsequently,aliquots can be removed from the container by syringe or the like.Alcohol or other compatible surface sterilizing agent can be used towipe the lip 62 and seal 64 before each use. Similar to the firstembodiment, it is additionally contemplated that a cap can be providedto fit over upper chamber lip 62 between use.

The adaptor valve 50 can be adapted to function as a medicament adaptorfor an intravenous container. In this case, the adaptor valve 50 isplaced on a medicament container for intravenous delivery and attachedvia tubing to an intravenous feed. Thus, the adaptor valve 50 can beplaced in fluid communication with a connector valve of FIG. 1 tofacilitate the flow of medicament from intravenous drip bottles.

An alternative embodiment of the seal, a seal 36 a, is shown in FIG. 9.Seal 36 a comprises a seal cap 92 at the proximal end thereof and a seallip 96 at the distal end thereof. A cup-like annular flange 95 isprovided proximal seal cap 92. The seal cap 92 and seal lip 96 areconnected by a seal wall consisting of a plurality of ringed wallportions 94 that expand and collapse in an accordion like fashion.During compression of the seal 36 a, the diameter of the ringed wallportions 94 expand outward in the radial direction. There are airpockets 13 a (FIG. 10) between ring portions 94 and the housing and airpockets 13 b between spike 24 and seal 36 a. The seal 36 a contains acavity 98 distal seal cap 92 and adjacent the ringed wall portions 94.The seal 36 a interacts with spike 26 (FIG. 2) and other components ofthe present invention in a similar fashion to seal 36 of FIG. 2.

Referring to FIG. 10, the cup-like annular flange 95 may be stretchedaround the upper conduit 20 and held in place by an annular ring 97.This creates a trampoline like effect that assists returning the seal 36a to a decompressed state after withdrawal of a syringe (not shown).This embodiment has two advantages. First, the proximal end of the valve10 can be swabbed with alcohol or other disinfectant without leakage ofdisinfectant into the valve 10. Second, by affixing cup-like annularflange 95 to upper conduit 20 at the proximal end thereof with annularring 97, the repeated deformation and reformation of the seal 36 a isassisted.

An alternative embodiment of the seal, a seal 36 b is shown inconnection with the valve 10 in FIG. 11. S The seal 36 b is similar tothe seal 36 a and is comprised of seal cap 92, a side wall consisting ofringed wall portions 94 and a seal lip 96. It also has an outwardlyextending ring 99 which is at a right angle with respect to thelongitudinal axis of the valve 10. This ring 99 is used to attach theseal 36 b to upper conduit 20. Preferably, an upper conduit annular plug20′ is inserted within upper conduit 20 to create a tight fit betweenperpendicular ring 99, a ledge 101 in the upper conduit 20, and the plug20′. The ring 99 assists in the reformation of seal 36 b to enclosespike 26 upon withdrawal of a syringe (not shown).

As shown in FIG. 12, the cup-like annular flange 95 and ring 99 may bothbe used in connection with the valve 10, to provide the seal 36 c. Thisseal 36 c, provides rapid reformation upon withdrawal of a syringe (notshown) and realizes the advantages of both the seals 36 a and 36 b.

Another alternative embodiment of the seal, a seal 36 d, is shown inFIG. 13. In this embodiment, the seal 36 d is comprised of seal cap 92,seal lip 96, and a side wall 150 comprised of circular tires 100 stackedin series one on top of an adjacent larger diameter lower tire. Thecircular tires 100 are preferably solid throughout the diameter of thecross-section thereof. These circular tires 100 will deform and reformupon, respectively, compression and decompression of the seal 36 d,thereby exposing or covering a spike (not shown) as the case may be.

As mentioned above, preferably seal 36 d has a precut slit 11 in the cap92 lying along the longitudinal axis of the valve 10. The seal cap 92has a unique configuration that insures that the slit 11 closes and issealed upon withdrawal of a syringe (not shown) and reformation of theseal 36 d. It includes an enlarged, internal, pressure responsive member200 which is integral with the cap 92. Between the proximal end of theside wall 150 and the member 200 is an annular space 102 which is filledwith the fluid in the cavity 98. This fluid is under pressure, forexample at the blood pressure of the patient to which the valve 10 isattached. Referring to FIG. 14, fluid, for example the patient's blood,flows through the holes 34 in the spike 26, filling the cavity 102. Thisfluid presses against the exterior of the member 200, closing the slit11 when the seal is decompressed as shown in FIGS. 14 and 19. Thepressure from this fluid creates a high pressure seal which preventsfluid from escaping valve 10 through the slit 11. There is asemi-cylindrical annular flange tear ring 104 on the end of the member200 which advantageously extends the useful life of seal 36 d.

Preferably, there is a tear ring 104 integral with the member 200 alongthe perimeter of the internal surface the member 200, and a slightsaucer-like depression 204 in the external surface of the seal. Thepressure responsive element in the decompressed state closes any orificein the seal 36 d to provide an essentially fluid-tight seal while in thedecompressed state. The pressure responsive member 200 enables the valveto maintain a fluid-tight seal even at very high pressures sometimesexperienced in medical applications, particularly when the valve 10 isconnected to a patient's artery. The center of the member 200 and theannular space 102 are coaxial with the entryway 11 a to the orifice 11.The pressurized fluid fills the annular space 102 to apply pressure thatcompresses the member 200 to tightly close the entryway to the orifice.In a preferred embodiment the distance from the entryway 11 a to theproximal end of seal cap 92 is from 0.500 to 0.075 inches and morepreferably approximately 0.100 inch.

As best illustrated in FIG. 22, the tip 32 is designed to avoid tearingthe seal. Tip 32 has three facets 210, 212, and 214 which are joinedwith each other along parting lines a, b, and c. This junction of thefacets 210, 212, and 214 frequently is ragged and will tear the seal 36d. This is prevented by the parting lines a, b, and c, or junctions,being disposed within recesses 220, 222, and 224, respectively, toprovide “buried parting lines.”

Another alternative embodiment of the present invention using the seal36 d is shown in FIG. 8 and FIGS. 19 through 21. In this embodiment, theinner wall 160 of the upper end of the conduit 20 is provided with atleast one, and preferably, a plurality of radial indentations 107. Theindentations 107 are elongated disposed generally parallel to thelongitudinal axis if the valve 10 in a symmetrical, star-likeconfiguration. Each indentation has opposed lateral edges 162 whichengage the seal 36 d upon compression of the seal 36 d. The indentationsprovide space into which the seal 36 d expands upon compression.

As best shown in FIG. 8, the wall 181 of the proximal end of the conduit20 is tapered inward at the same angle as the nose 48 of the syringe 46.In accordance with ANSI standards, the taper is 0.006 inch per linearinch. The wall 182 of the syringe nose 48 bears against the wall 181 asthe nose slides into the opening 25 a to push the seal 36 d inwardcompressing it and forcing the tip 32 of the spike 36 to enter the slit11. The seal 36 d expands upon compression to fill essentiallycompletely the upper portions of the indentations 107. Some sections ofthe seal 36 d are wedged between the edges 162 and other sections fillthe indentations 107. As the liquid flows through the nose 48 throughholes 34, air in the nose 48 is forced out of the nose 48 and expelledfrom valve 10 between walls 181 and 182. Thus, essentially the entireprescribed dosage is delivered through valve 10 to the patient. Fluidflows through the through-holes 34, but does not leak between either theseal 36 d and the wall 181 or between the abutting walls 181 and 182.

FIGS. 15, 16, 17, and 18 depict embodiments of seals, namely, seal 36 e,seal 36 f, and seal 36 g, which are substantially the same as the seals36 a (FIG. 10), seal 36 b (FIG. 11), and seal 36 c (FIG. 12), except theside wall 150 employing the circular tires 100 is used in place of theaccordion wall portion 94.

Other components of the present invention interact with the variousembodiments of the seal in a similar fashion to their interaction withseal 36 of FIG. 2. Prior to use of valve 10, it is preferable that theseal caps 40 or 92 be pierced centrally by a steel needle in the axialdirection, precutting the seal to provide the slit 11 in order to allowfor more rapid decompression and reformation of the seal upon piercingby the spike 26. The seals are advantageously formed from a materialwhich can repeatedly reseal and prevent fluid from flowing around theseal material. The seal 36 should also be capable of being forced downand then spring back into position to reseal the valve. Material that istoo soft will reseal effectively; however, will not be capable ofspringing back after opening of the valve. Material that is too hardwill provide sufficient spring force; however, will not effectivelyseal. Thus, in a preferred embodiment, the seal is formed from asilicone having a hardness in the range from 30-70 Shore durometerunits, and more preferably in the range 40-50 Shore durometer units. Acure silicone polymer in the preferred hardness range is available fromWacker Silicone Corp. of Adrian, Mich. In some embodiments of theinvention, it is desirable to provide additional lubricity to the seal36 to allow it to spring back and reseal more effectively. Dow ChemicalCo. produces a silicone formulation with silicone oil built in toprovide this additional lubricity.

In general, the closing of the valve 10 is provided not by the side wallof the seal 36 which immediately covers the through-holes 34, but by theseal cap 40, or seal cap 92 filling the proximal end of the cavity 98and the opening 25 a. Thus, the seal caps 40 and 92 are sufficientlythick to reseal the opening 25 a effectively after valve closure.However, the seal caps 40 and 92 should also be sufficiently thin toallow them to readily return to the closed position. Preferably thethickness of the caps 40 and 92 ranges between 0.075 and 0.500 inch andmore preferably may be approximately 0.100 inch.

The valve disclosed in this invention can be provided in a sterile anddisposable form such that after its use in a given installation isexhausted, the device is discarded. However, as described above, in anygiven installation, the device can be reused multiple times. Since thedevice does not employ needles, there is little chance that the devicewill inadvertently cause skin puncture. Therefore, the extra precautionsrequired for handling and disposing of needles is obviated. It will beapparent from the detailed description provided herein that the presentinvention can provide for the elimination of nearly all needles used inthe medical environment. With the use of the valve of the presentinvention, the need for all needles except those that are directly inputinto a patient is, advantageously, eliminated.

Operation

The valve 10 is used to provide a closed, patient access system fortransferring a predetermined amount of medication from a remote sourceto the patient. The valve 10 is connected by the distal end to thepatient, for example, a vein or artery in fluid communication with thevalve. Blood fills the valve, but the seal 36 d, for example, preventsany blood from leaking from the valve. The delivery end or nose 48 ofthe medical implement is inserted into the valve as depicted in FIG. 8,pushing the nose 48 against the seal to compress the seal sufficientlyto allow the tip 32 of the spike 24 to pierce the seal and enter saiddelivery end. The predetermined amount of medication in its entirety maynow be transferred through the nose 48 into the valve 10 and into thepatient. Since the nose 48 and seal 36 d engage in a manner so that thetip 32 of the spike element 24, upon piercing the seal, meets the sealto avoid formation of any dead space at the interface between nose 48and the seal surface 40 b. Transfer directly through the valve 10 ofessentially the entire predetermined amount of medication from thesyringe 46 to the patient, so that essentially none of saidpredetermined amount is collected in any dead space in the valve, isaccomplished with this invention. Upon withdrawing the nose 48 from thevalve 10 the seal 36 d returns to the decompressed state to close thevalve and maintain while in said decompressed state a fluid tight sealeven at high pressures and after repeated uses.

Scope of the Invention

The above presents a description of the best mode contemplated ofcarrying out the present invention, and of the manner and process ofmaking and using it, in such full, clear, concise, and exact terms as toenable any person skilled in the art to which it pertains to make anduse this invention. This invention is, however, susceptible tomodifications and alternate constructions from that discussed abovewhich are fully equivalent. Consequently, it is not the intention tolimit this invention to the particular embodiments disclosed. On thecontrary, the intention is to cover all modifications and alternateconstructions coming within the spirit and scope of the invention asgenerally expressed by the following claims, which particularly pointout and distinctly claim the subject matter of the invention.

1. A flexible element for use with a medical connector, comprising aproximal end, a distal end, and a flexible wall with an inner surfaceand an outer surface, the flexible element further defining a firstregion adjacent the proximal end, a second region, and a third regionnear the distal end, the second region being between the first and thirdregions, the outer surface in the first region having at least a firstexternal cross-sectional width, the outer surface in the second regionhaving at least a second external cross-sectional width, and the outersurface in the third region having at least a third external crosssectional width, the second external cross-sectional width beingdifferent than the first and third cross-sectional widths, the innersurface in the first region having at least a first internalcross-sectional width, the inner surface in the second region having atleast a second internal cross-sectional width, the inner surface in thethird region having at least a third internal cross-sectional width, thesecond internal cross-sectional width being different than the first andthird internal cross-sectional widths, the proximal end including a capand an orifice wherein the shape of the cap assists in closing theorifice.